MultiCode® Mycoplasma pneumoniae Primers - Nucleic acid sequences, which, through specific - LUMINEX CORPORATION

Duns Number:079686463

Device Description: Nucleic acid sequences, which, through specific binding or chemical reaction with substanc

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More Product Details

Catalog Number

3927

Brand Name

MultiCode® Mycoplasma pneumoniae Primers

Version/Model Number

3927

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

Product Characteristics

MRI safety Status

Labeling does not contain MRI Safety Information

Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)

-

Device labeled as "Not made with natural rubber latex"

-

For Single-Use

-

Prescription Use (Rx)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

-

Product Code Details

Product Code

MVU

Product Code Name

REAGENTS,SPECIFIC,ANALYTE

Device Record Status

Public Device Record Key

5b7ad1ed-3e8e-4164-8e77-1ade109bb300

Public Version Date

March 29, 2018

Public Version Number

2

DI Record Publish Date

December 16, 2016

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"LUMINEX CORPORATION" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 47
2 A medical device with a moderate to high risk that requires special controls. 52